Total 5 job vacancies by 3205 St. Jude Medical, Cardiology Division, I

JOB DESCRIPTION:

R&D Program Manager

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to:

• Career development with an international company where you can grow the career you dream of.

• Free medical coverage for employees* via the Health Investment Plan (HIP) PPO

• An excellent retirement savings plan with high employer contribution

• Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.

• A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.

• A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

This position works out of our Plymouth, MN location in the Structural Heart medical devices division. Our business purpose is to restore health and improve quality of life through the design and provision of device and management solutions for the treatment of structural heart disease.

The Program Manager manages programs of small to medium scope, or a significant subsection of a large program. Sr. Managers manage larger programs.  Leads cross-functional teams to develop and execute strategies for new product development and successful commercialization.  Manages matrixed resources to ensure programs meet their agreed upon milestones and deliverables.  Represents the program to the organization, reports core team progress, program recommendations, risks, and resolutions of issues to senior leadership.

What You'll Work On:

• Lead core teams towards program objectives.

• Communicates with all levels of the organization, from operators on the floor to the President in order to represent the objectives, risks, and needs for the program.

• Lead activities across numerous functions to meet the objectives of a given program including scope, budget, and schedule.

• Establish and maintain the program and product Design History File.

• In partnership with the Program Director and fellow core team members,

• Develop comprehensive program plans, which identify objectives, strategy, risks/risk mitigation, budget, effort estimates and schedule for new product development.

• Identifies opportunities for improving overall business performance of the program.

• Develops plans with core members to eliminate and/or mitigate risk.  If risks cannot be mitigated within the core team, determines appropriate means to communicate and elevate issues to appropriate individuals within the organization

• In partnership with the Director, identifies opportunities for improving overall performance of the program.

•  Work closely with functional core team leaders and mentor when necessary.

• Maintains a safe and professional work environment.

• Complies with worldwide medical device regulations including U.S. FDA, company policies and Good Manufacturing Practices.

• Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

Required Qualifications:

• 8+ years of experience required for progressively responsible experience in engineering or related technical discipline.

• 5 years of Project Management experience preferred.

• Minimum 5 years experience in leading projects in a medical device, biomedical or high technology industry.

• Ability to work in a matrixed and geographically diverse business environment. Strong leadership skills, including the ability to set goals and provide constructive feedback respectfully to build positive relationships and improve business results. Ability to work effectively within a team in a fast-paced changing environment.  Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.  Multi-tasks, prioritizes and meets deadlines in timely manner. Strong organizational, planning, and follow-up skills and ability to hold others accountable. 

• Preferred: 3 years’ experience directly managing technical staff. Extensive medical device industry experience. Program/Project Management certifications. Experience working in a broader enterprise/cross division business unit model. 

• Ability to travel approximately 10% of the time, including internationally.

* Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives:  www.abbottbenefits.com

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.

Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews.

The base pay for this position is

In specific locations, the pay range may vary from the range posted.

JOB FAMILY:

DIVISION:

LOCATION:

ADDITIONAL LOCATIONS:

WORK SHIFT:

TRAVEL:

MEDICAL SURVEILLANCE:

SIGNIFICANT WORK ACTIVITIES:

JOB DESCRIPTION:

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to:

• Career development with an international company where you can grow the career you dream of.
• Free medical coverage for employees* via the Health Investment Plan (HIP) PPO
• An excellent retirement savings plan with high employer contribution
• Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.
• A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
• A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.

In Abbott’s Electrophysiology (EP) business, we’re advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives.

The Opportunity

The Regulatory Affairs Manager will work out of our Maple Grove, MN location for our Electrophysiology division. As a manager, the function of a Manager Regulatory Affairs is to combine knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or distributed to meet required legislation. This new team member will develop and supervise regulatory professionals as well as share knowledge and expertise with others in support of team activities. The individual has department/group/site level influence and is generally recognized as an expert and resource within the department. This Regulatory Affairs Manager may analyze broad scope implications of changing regulations and guidance. Additionally, may identify data needed, obtain this data, and ensure that they are effectively presented for the registration of products worldwide.

What You’ll Work On

• Develop new regulatory policies, processes and SOPs and train key personnel on them.  Evaluate regulatory risks of division policies, processes, procedures. Recruit, develop and manage regulatory professionals.
• Provide regulatory input to product lifecycle planning. Monitor regulatory outcomes of initial product concepts and provide input to senior regulatory management. Provide strategic input and technical guidance on regulatory requirements to development teams.
• Assist in the development of multi-country regulatory strategy and update strategy based upon regulatory changes.
• Assist in regulatory due diligence for potential and new acquisitions.
• Utilize technical regulatory skills to propose strategies on complex issues. Determine submission and approval requirements. Identify emerging issues.
• Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with other members of regulatory and related teams. Monitor trade association positions for impact on company products.
• Assess the acceptability of quality, preclinical and clinical documentation for submission filing. Compile, prepare, review and submit regulatory submission to authorities.
• Evaluate risk of and regulatory solutions to product and clinical safety issues during clinical phases and recommend solutions.
• Monitor impact of changing regulations on submission strategies and update internal stakeholders. Monitor applications under regulatory review. Communicate application progress to internal stakeholders. Monitor and submit applicable reports and ensure appropriate responses are submitted to regulatory authorities.
• Evaluate proposed preclinical, clinical and manufacturing changes for regulatory filing strategies.
• Negotiate and interact with regulatory authorities during the development and review process to ensure submission approval.
• Manage and execute preapproval compliance activities.
• Oversee processes involved with maintaining annual licenses, registrations, listings and patent information. Ensure compliance with product post-marketing approval requirements. Review and approve advertising and promotional items to ensure regulatory compliance. Ensure external communications meet regulations.
• Develop, implement and manage appropriate SOPs and systems to track and manage product-associated events. Actively contribute to the development and functioning of the crisis/issue management program. Analyze product-associated problems and develop proposals for solutions.
• Oversee system to ensure that product safety issues and product-associated events are reported to regulatory agencies. Report adverse events to regulatory agencies and internal stakeholders. Provide regulatory input for product recalls and recall communications.
• Individuals execute and manage technical and scientific regulatory activities. Must function independently as a decision-maker on regulatory issues and must assure that deadlines are met.
• Work is performed without appreciable direction and exercises some latitude in determining technical objectives of assignments. Completed work is reviewed from a relatively long- term perspective for desired results. Individual is recognized as a discipline expert and resource in regulatory affairs.
• Develops, communicates, and builds consensus for operating goals that are in alignment with the division.  Provides leadership by communicating and providing guidance towards achieving department objectives.  Interfaces with a variety of management levels on significant matters, often requiring the coordination of activity across organizational units. May lead a cross-functional or cross-divisional project team. Provides technical leadership to business units. Acts as a mentor to less-experienced staff. Exercises judgment independently.
• Creates immediate to long-range plans to carry out objectives established by top management. Develops and calculates a budget for a department or group to meet organizational goals. Forecasts future needs including human and material resources and capital expenditures. Recommends or modifies the structure of organizational units or a centralized functional activity subject to senior management approval.
• Assignments are expressed in the form of objectives Makes decisions regarding work processes or operational plans and schedules in order to achieve the program objectives established by senior management. Consequences of erroneous decisions or recommendations would normally include critical delays and modifications to projects or operations with substantial expenditure of time, human resources, and funds, and may jeopardize future business activity.

Required Qualifications

• Bachelor's degree (or equivalent)
• 4-5 years’ experience in a regulated industry (e.g., medical products, nutritionals). Note: Higher education may compensate for years of experience.
• 2-5 years of experience in regulatory preferred but may consider quality assurance, research and
• development/support, scientific affairs, operations, or related area.
• Effectively communicate verbally and in writing, prepare, and negotiate both internally and externally with various regulatory agencies.
• Ability to work effectively on cross-functional teams.
• Pay strong attention to detail.
• Organize and track complex information.
• Exercise good and ethical judgment within policy and regulations
• Use in-depth knowledge of business functions and cross group dependencies/ relationships.
• Follow scientific arguments, identify regulatory scientific data needs and solve regulatory issues.

Preferred Qualifications

• Bachelor's degree in science (biology; chemistry; microbiology; immunology; medical technology; pharmacy; pharmacology); math; engineering; or medical fields.
• M.S. in a technical area or MBA. A Ph.D. in a technical area or law is helpful.
• Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.)
• Previous experience with 510k / PMA submissions.
• Prior experience supervising and coaching a team.
• Experience with Medical Devices.
• Must be able to juggle multiple and competing priorities.
• Exercise judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
• Has a sound knowledge of a variety of alternatives and their impact on the business.

Apply Now

* Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives:  www.abbottbenefits.com

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.

Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews.Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.

The base pay for this position is

In specific locations, the pay range may vary from the range posted.

JOB FAMILY:

DIVISION:

LOCATION:

ADDITIONAL LOCATIONS:

WORK SHIFT:

TRAVEL:

MEDICAL SURVEILLANCE:

SIGNIFICANT WORK ACTIVITIES:

JOB DESCRIPTION:

Category & Supplier Strategy Manager

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to:

• Career development with an international company where you can grow the career you dream of.
• Free medical coverage for employees* via the Health Investment Plan (HIP) PPO
• An excellent retirement savings plan with high employer contribution
• Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.
• A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
• A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

This role will be with the Abbott Electrophysiology Division and work be located in Plymouth, MN.  In Abbott’s Electrophysiology (EP) business, we’re advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives.

The Category and Supplier Relationship team within Electrophysiology is responsible for the development and execution of category and supplier strategy for all direct material purchases.   This role will support and influence internal/external stakeholders to ensure engagement, alignment, and business readiness to drive improvements in quality, sustainability, supply chain risk, total cost of ownership, and technological capability of our supply base. This divisional role provides an opportunity to lead and work within diverse multi-functional teams and will collaborate with Global Procurement other Abbott Divisions.

What You’ll Work On

• Develop and guide implementation of category and supplier management strategies which support business growth and profitability objectives.
• Provides vision, leadership and direction withing the Category Strategy & Supplier Relationship Organization.
• Support annual operating plan,  long term goal setting (KPIs).
• Develop and lead long-term, customer focused supply chain solutions (VMI, Kanban, Supplier Portals,).
• Lead Category or Supplier Managers, who select global strategic suppliers, negotiate large complex development and supply contracts, develop supply chain commodity management strategies, prepare cost analysis, negotiate and manage contracts, and manage supplier relations.
• This position will provide strategy and contract negotiation leadership to the organization, with specific emphasis on complex contracts for Third Party Manufacturing/Outsourcing and Electronics Categories. 
• Additionally, this position needs to work directly with Program Management, R&D and New Product engineering teams to create effective supply chain strategies.
• This position also partners with Supply Chain Project leaders in the support of special projects and improvement objectives.
• Leverages core business systems (SAP) and various software technologies to provide continuous improvements.
• Drive initiatives for development and redesign of processes that optimize carrying cost, operational cost, obsolescence cost, and service levels.

Required Qualifications

• Bachelor’s degree in Business, Engineering, Computer Science, Finance or related field.
• Progressively responsible experience in materials management/purchasing.
• 7 years’ experience working in a highly regulated environment and proven familiarity with applicable regulations.
• 5 years’ experience working with MRP, DRP, ERP, forecasting, inventory management within SAP or similar system software.
• Experience managing teams.
• Experience leading cross functional projects and teams.
• Ability to travel approximately 10% - 25%, including internationally

Preferred Qualifications

• Masters' degree preferred.
• Experience negotiating complex contract terms with vendors, suppliers and contractors.
• Medical device or related industry experience is preferred.

* Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives:  www.abbottbenefits.com

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.

Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.

The base pay for this position is

In specific locations, the pay range may vary from the range posted.

JOB FAMILY:

DIVISION:

LOCATION:

ADDITIONAL LOCATIONS:

WORK SHIFT:

TRAVEL:

MEDICAL SURVEILLANCE:

SIGNIFICANT WORK ACTIVITIES:

JOB DESCRIPTION:

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to:

• Career development with an international company where you can grow the career you dream of.
• Free medical coverage for employees* via the Health Investment Plan (HIP) PPO
• An excellent retirement savings plan with high employer contribution
• Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.
• A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
• A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

This position works out of our Plymouth, MN location in the Electrophysiology division. In Abbott’s Electrophysiology (EP) business, we’re advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives.

The Staff Supplier Quality Engineer is responsible for driving improvement and corrective action in the quality of components sourced from outside suppliers. Provides technical support in the selection of suppliers. Develops acceptance criteria for materials. Monitors supplier performance to drive supplier corrective action, manufacturing yield issues and field failures. 

What You’ll Work On

• Lead project teams of moderate scope for activities related to Supplier Change Notifications
• Assess potential new suppliers for technical, quality and manufacturing capabilities. 
• Provides technical support for the introduction of components from a new supplier. 
• Generates and maintains incoming inspection procedures. 
• Assists in generating component specifications. 
• Generate test protocols, monitor testing, issue qualification test reports and approve components for use in products. 
• Analyzes incoming material defects. 
• Dispositions and drives corrective action as necessary. 
• Communicates issues to suppliers. 
• Reviews specifications and provides input from component quality and manufacturability perspective. 
• Investigates field failures related to supplier materials. 
• Develop corrective action plan where necessary 
• May supervise Supplier Quality Engineers or technicians. 
• Cultivates a wide range of internal networks and begins to develop an extensive external network of resources to facilitate completion of tasks. 
• Provides guidance to less experienced staff. Acts as a mentor to lower level individual contributors. Influence exerted at peer level and occasionally at first levels of management. 
• Plans, organizes, and prioritizes own daily work routine to meet established schedule. 
• Exercises authority and judgment within defined limits to determine appropriate action. Failure to achieve results or erroneous decisions or recommendations may cause delays in program schedules and may result in the allocation of additional resources. 
   

Required Qualifications

• BS degree in Engineering or Technical Field or equivalent experience; advanced degree preferred
• 8+ years’ Engineering experience and demonstrated use of Quality tools/methodologies
• Detailed knowledge of FDA, GMP, ISO 13485, ISO 9001
• Solid communication and interpersonal skills
• Advanced computer skills, including statistical/data analysis and report writing skills
• Ability to work in a highly matrixed and geographically diverse business environment
• Ability to work within a team and as an individual contributor in a fast-paced, changing environment
• Ability to leverage and/or engage others to accomplish projects
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization
• Multitasks, prioritizes and meets deadlines in timely manner
• Strong organizational and follow-up skills, as well as attention to detail
• Ability to travel approximately 10%
• Ability to maintain regular and predictable attendance

Preferred Qualifications

• Training and/or Certification to ISO13485
• Project management and leadership skills, including the demonstrated ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner
• Prior medical device (implantable) manufacturing experience preferred but not necessary.
• Experience implementing various product and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing)

Apply Now

* Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives:  www.abbottbenefits.com

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.

Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.

The base pay for this position is

In specific locations, the pay range may vary from the range posted.

JOB FAMILY:

DIVISION:

LOCATION:

ADDITIONAL LOCATIONS:

WORK SHIFT:

TRAVEL:

MEDICAL SURVEILLANCE:

SIGNIFICANT WORK ACTIVITIES:

JOB DESCRIPTION:

Senior R&D Engineer

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to:

• Career development with an international company where you can grow the career you dream of .

• Free medical coverage for employees* via the Health Investment Plan (HIP) PPO

• An excellent retirement savings plan with high employer contribution

• Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.

• A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.

• A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.

Our location in Plymouth, MN, currently has an opportunity for a Sr. R&D Engineer.   We are looking for a highly motivated, innovative, experienced, collaborative, and technically strong engineer to join our winning team!  This role will support our Structural Heart team. Our business purpose is to restore health and improve quality of life through the design and provision of device and management solutions for the treatment of structural heart disease.

The Opportunity

• Takes a leadership role in developing new concepts from initial design to market release.

• Researches, develops, designs, and evaluates materials, components, and assemblies.

• Develops strong understanding of customer requirements and design requirements.

• Designs and builds prototypes and conducts testing to characterize, verify, and validate performance.

• Maintains detailed documentation throughout all phases of research and development.

• Provides engineering support for released products as needed.

• Creates and submits intellectual property (patents).

• Reviews or coordinates vendor activities to support product development activities.

• Thinks critically, problem solves, communicates clearly both in spoken and written form, and works effectively in a collaborative team environment.

• Able to work autonomously using sound judgement and work collaboratively using strong interpersonal skills.

• Responsible for compliance with applicable Corporate and Divisional Policies and procedures.

• Provides technical direction to machinists / technicians and provides helpful feedback to other engineers.

Required Experience

• Bachelor’s Degree in Mechanical Engineering, Biomedical, or other related engineering field.

• 6+ years of medical device work experience, primarily in R&D engineering.

• Strong technical knowledge including a demonstrated ability to think critically, problem solve, communicate clearly both in spoken and written form, and work effectively in a collaborative team environment.

• Significant experience working on engineering applications within a medical device company. 

• Demonstrated ability to effectively take on assignments of moderate to large scope.

• Advanced analytical and troubleshooting skills.

Preferred Experience

• Master’s Degree in related engineering field.

• Proficient in SolidWorks.

• Experience building and leveraging internal and external networks.

• Significant test method development/validation experience.

• Experience leading projects and influencing others.

• Experience providing direction to technicians and other engineers.

• Experience with all phases of the product development process from early-stage innovation through design transfer.

• Track record of successfully working through difficult engineering problems.

* Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives:  www.abbottbenefits.com

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.

Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews.

The base pay for this position is

In specific locations, the pay range may vary from the range posted.

JOB FAMILY:

DIVISION:

LOCATION:

ADDITIONAL LOCATIONS:

WORK SHIFT:

TRAVEL:

MEDICAL SURVEILLANCE:

SIGNIFICANT WORK ACTIVITIES: